Augmedics, a startup developing augmented reality surgical guidance technology, has received FDA clearance for its Xvision Spine system following the completion of a laboratory study with Chicago-based Rush University Medical Center.
The XVS system comprises a near-eye-display headset that connects to traditional surgical navigation software and superimposes a virtual trajectory onto patient CT scan data. This 3D path is projected onto the retina of the surgeon wearing the headset, who can then perform the surgery and navigate around surgical instruments and implants without looking away from the patient.
In the percutaneous lab study, Rush investigators used Augmedics' system to position 93 screws in the thoracic and sacro-lumbar areas of five cadavers, achieving a clinical accuracy rate of 98.9 percent.
"The efficiency and accuracy this augmented reality technology enables in placing spinal implants without looking away from the surgical field — as well as the ability to 'see the spine' through the skin in minimally invasive procedures — differentiates the Xvision from conventional spinal navigation platforms," Frank Phillips, MD, professor of orthopedic surgery at Rush University Medical Center, said in a news release. "The economics of the Xvision system are also compelling in both the hospital and the surgicenter environment."
With its FDA clearance, the XVS system is now available for sale in the U.S. Distribution is planned for early 2020.